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RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Ketamine Hydrochloride for Healthy Volunteers

Background: There are no good treatments for people considering suicide. Researchers want to study suicide with questions, blood tests, brain imaging, and sleep studies.

Official registry: https://clinicaltrials.gov/study/NCT02543983 · National Institute of Mental Health (NIMH) · enrollment listed as 325

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Magnetic Resonance Imaging scanner, 3T, NeurOptics PLRTM-3000 Pupillometer, or Experimental Anxiety Devices. The registry lists allocation as na. Background: There are no good treatments for people considering suicide.

They plan to enroll about 325 people at Bethesda. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.

Official title (unrewritten)

The Neurobiology of Suicide

Interventions: Magnetic Resonance Imaging scanner, 3T, NeurOptics PLRTM-3000 Pupillometer, Experimental Anxiety Devices, Magnetic Resonance Imaging scanner, 7T, Ketamine Hydrochloride

Primary outcome (registry wording): Study as Whole: Psychiatric, psychological, neuroimaging, sleep and biological differences between participants in Groups 1, 2, 3, 4, and 5

Who it is for (from inclusion criteria)

  • Ages 18 Years to 70 Years
  • Phase I: Groups 1-3 and 5 (Patients)
  • 18 to 70 years of age
  • Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase I
  • Additional Criteria for Group 1 (Active Crisis): Agree to be hospitalized
  • Phase I: Group 4 (Healthy Volunteers)
  • Phase II: Group 1 (Active Crisis) and Group 5 (Suicide Ideators)
  • Patients must have completed Study Phase I as a participant in Group 1 or 5

Public study contact (from the registry)

Laura R Waldman, L.C.S.W.

(301) 768-2833

laura.waldman@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT02543983 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT02543983?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT02543983?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary